AJOB Primary Research

Background: Recruiting and retaining human participants in cancer clinical trials is challenging for many investigators. Although we expect participants to identify and weigh the benefits and burdens of research participation for themselves, it is not clear what burdens adult cancer participants perceive in relation to benefits. We identify key attributes and develop an initial conceptual framework of benefit and burden based on interviews with individuals enrolled in cancer clinical research. Methods: Semistructured interviews were conducted with a purposive sample of 32 patients enrolled in cancer clinical trials at a large northeastern cancer center. Krueger's guidelines for qualitative methodology were followed. Results: Respondents reported a range of benefits and burdens associated with research participation. Benefits such as access to needed medications that subjects otherwise might not be able to afford, early detection and monitoring of the disease, potential for remission or cure, and the ability to take control of their lives through actively participating in the trial were identified. Burdens included the potentiality of side effects, worry and fear of the unknown, loss of job support, and financial concerns. Conclusions: Both benefit and burden influence research participation, including recruitment and retention in clinical trials. Dimensions of benefit and burden include physical, psychological, economic, familial, and social. Understanding the benefit–burden balance involved in the voluntary consent of human subjects is a fundamental tenet of research and important to ensure that subjects have made an informed decision regarding their decision to participate in clinical research.

Connie M. Ulrich

Kathleen A. Knafl

Sarah J. Ratcliffe

Therese S. Richmond

Christine Grady

Claiborne Miller-Davis

Gwenyth R. Wallen

Developing a Model of the Benefits and Burdens of Research Participation in Cancer Clinical Trials

开发癌症临床试验参与的利弊模型

Background: Although moral distress is increasingly recognized as an important problem that threatens the integrity of health care providers and health care systems, few reliable and valid measures of moral distress are currently in use in research or clinical practice. This article describes the development and testing of a revised measure of moral distress, the Moral Distress Scale–Revised (MDS-R), designed for use in multiple health care settings and with multiple disciplines. Methods: After instrument development and content validity testing, a survey methodology was used to assess reliability and construct validity of the MDS-R. Registered nurses (n = 169) and physicians (n = 37) in eight intensive care units (ICUs) at an academic medical center in the southeastern United States participated; the survey was administered during a 2-week period in January 2011. Results: Adequate reliability and evidence of construct validity were demonstrated. Moral distress was significantly higher for nurses than physicians, although it was negatively correlated with ethical climate for both provider groups. MDS-R scores were significantly higher for those clinicians considering leaving their positions. The proportion of physicians and nurses who had left a previous position or who were considering leaving their current positions due to moral distress was high (16% and 31%, respectively). Conclusions: Initial testing of the MDS-R reveals promising evidence of instrument reliability and validity. The findings from this study lend further support to the important relationships between the moral distress of providers, the ethical climate of health care settings, and retention of health care professionals.

Ann Baile Hamric

Christopher Todd Borchers

Elizabeth Gingell Epstein

Development and Testing of an Instrument to Measure Moral Distress in Healthcare Professionals

医疗保健专业人员道德困扰测量工具的开发与测试

Informed consent is regarded as a pillar of medical ethics. The purpose of this study was to evaluate perceptions of the informed consent process prior to surgery. Three hundred elective surgery patients were randomly selected from three teaching hospitals in Kashan, Iran, and asked to complete a questionnaire about four key aspects of the informed consent process: information disclosure, voluntariness, comprehension, and their relationship with physicians. Data were scored and analyzed using univariate and multivariate methods. Based on the responses, the perceived quality of information disclosure (7.96 ± 4.9 out of 18 points), comprehension of the consent form (0.55 ± 1.1 out of 4 points), and voluntariness (1.73 ± 2.1 out of 8 points) were considered to be unacceptable and the perceived quality of the physician–patient relationships (10.6 ± 4.1 out of 14 points) acceptable. Most of the participants (88.7%) reported that they had requested to be informed about the complications of the surgical procedures, including severe complications such as death, but most of them did not receive this information. The most important factors associated with the perceived quality of informed consent were the patient's level of education and type of surgery. In conclusion, practices consistent with the principles of informed consent have not been adequately implemented in the surgical departments of these hospitals in Kashan. To improve current practices, patients should receive more information about the risks and benefits of surgery as well as any available alternatives. Information about the expected length of hospital stay, post-discharge follow-up, and the cost of surgery should also be provided to patients. To improve the perceived quality of the informed consent process, more emphasis should be placed on ensuring that patients receive the requested information in a manner they can comprehend. Redesigning consent forms may be an important step in improving the patients’ experience of the informed consent process.

Abass Sheikhtaheri

Mehrdad Farzandipour

Factors Associated with Quality of Informed Consent in Patients Admitted for Surgery: An Iranian Study

手术患者知情同意质量相关因素：一项伊朗研究

Mildred K. Cho

ELSI Research and Genetics: A Co-Evolution

ELSI研究与遗传学：共同进化

Background: To promote effective genome-scale research, genomic and clinical data for large population samples must be collected, stored, and shared. Methods: We conducted focus groups with 45 members of a Seattle-based integrated health care delivery system to learn about their views and expectations for informed consent in genome-scale studies. Results: Participants viewed information about study purpose, aims, and how and by whom study data could be used to be at least as important as information about risks and possible harms. They generally supported a tiered consent approach for specific issues, including research purpose, data sharing, and access to individual research results. Participants expressed a continuum of opinions with respect to the acceptability of broad consent, ranging from completely acceptable to completely unacceptable. Older participants were more likely to view the consent process in relational—rather than contractual—terms, compared with younger participants. The majority of participants endorsed seeking study subjects' permission regarding material changes in study purpose and data sharing. Conclusions: Although this study sample was limited in terms of racial and socioeconomic diversity, our results suggest a strong positive interest in genomic research on the part of at least some prospective participants and indicate a need for increased public engagement as well as strategies for ongoing communication with study participants.

Susan Brown Trinidad

Stephanie M. Fullerton

Julie M. Bares

Gail P. Jarvik

Eric B. Larson

Wylie Burke

Informed Consent in Genome-Scale Research: What Do Prospective Participants Think?

基因组规模研究中的知情同意：潜在参与者怎么想？

Abstract Background: A recent national survey revealed that over half of obstetrician-gynecologists working in Catholic hospitals have conflicts with religious policies, but the survey did not elucidate the nature of the conflicts. Our qualitative study examines the nature of physician conflicts with religious policies governing obstetrician-gynecologist (ob-gyn) care. Results related to restrictions on the management of obstetric complications are reported here. Methods: In-depth interviews lasting about one hour were conducted with obstetrician-gynecologists throughout the United States. Questions focused on physicians’ general satisfaction with their hospital work settings and specific experiences with religious doctrine-based ob-gyn policies in the various hospitals where they have worked. Results: Conflicts reported here include cases in which Catholic hospital religious policy (Ethical and Religious Directives for Catholic Health Care Services) impacted physicians’ abilities to offer treatment to women experiencing certain obstetric emergencies, such as pregnancy-related health problems, molar pregnancy, miscarriage, or previable premature rupture of membranes (PPROM), because hospital authorities perceived treatment as equivalent to a prohibited abortion. Physicians were contractually obligated to follow doctrine-based policies while practicing in these Catholic hospitals. Conclusions: For some physicians, their hospital's prohibition on abortion initially seemed congruent with their own principles, but when applied to cases in which patients were already losing a desired pregnancy and/or the patient's health was at risk, some physicians found the institutional restrictions on care to be unacceptable. Keywords: obstetrical emergenciesobstetric complicationsabortionmiscarriageCatholic health careCatholic bioethicsphysiciansqualitativein-depth interviews Notes All initials are pseudonyms.

Lori R. Freedman

Debra B. Stulberg

Conflicts in Care for Obstetric Complications in Catholic Hospitals

天主教医院中产科并发症护理的冲突

Wrongdoing among physicians and researchers causes myriad problems for patients and research participants. While many articles have been published on professional wrongdoing, our literature review found no studies that examined the rich contextual details of large sets of historical cases of wrongdoing.We examined 100 cases of wrongdoing in healthcare delivery and research using historiometric methods, which involve the statistical description and analysis of coded historical narratives. We used maximum variation, criterion-based sampling to identify cases involving 29 kinds of wrongdoing contained in a taxonomy of wrongdoing developed for the project. We coded the presence of a variety of environmental and wrongdoer variables and rated the severity of wrongdoing found in each case. This approach enabled us to (a) produce rich descriptions of variables characterizing cases; (b) identify factors influencing the severity of wrongdoing; and (c) test the hypothesis that professional wrongdoing is a unified, relatively homogenous phenomenon such as "organizational deviance."Some variables were consistently found across cases (e.g., wrongdoers were male and cases lasted more than 2 years), and some variables were consistently absent across cases (e.g., cases did not involve wrongdoers who were mistreated by institutions or penalized for doing what is right). However, we also found that some variables associated with wrongdoing in research (such as ambiguous legal and ethical norms) differ from those associated with wrongdoing in healthcare delivery (such as wrongdoers with a significant history of professional misbehavior).Earlier intervention from colleagues might help prevent the pattern we observed of repeated wrongdoing across multiple years. While some variables characterize the vast majority of highly publicized cases of wrongdoing in healthcare delivery and research-regardless of the kind of wrongdoing-it is important to examine and compare sets of relatively homogenous cases in order to identify factors associated with wrongdoing.

James M. DuBois

Emily E. Anderson

John T. Chibnall

Understanding the Severity of Wrongdoing in Health Care Delivery and Research: Lessons Learned From a Historiometric Study of 100 Cases

理解医疗保健提供和研究中不当行为的严重性：从100个案例的历史计量学研究中吸取的教训

There has been a recent growth in empirical research on assent with pediatric populations, due in part, to the demand for increased participation of this population in biomedical research. Despite methodological limitations, studies of adolescent capacities to assent have advanced and identified a number of salient psychological and social variables that are key to understanding assent.

David G. Scherer

Janet L. Brody

Robert D. Annett

Charles Turner

Jeanne Dalen

Yesel Yoon

Empirically Derived Knowledge on Adolescent Assent to Pediatric Biomedical Research

青少年同意参与儿科生物医学研究的实证知识

The role of front-line researchers, those whose responsibilities include face-to-face contact with participants, is critical to ensuring the responsible conduct of community-based drug use research. To date, there has been little empirical examination of how front-line researchers perceive the effectiveness of ethical procedures in their real-world application and the moral stress they may experience when adherence to scientific procedures appears to conflict with participant protections.This study represents a first step in applying psychological science to examine the work-related attitudes, ethics climate, and moral dilemmas experienced by a national sample of 275 front-line staff members whose responsibilities include face-to-face interaction with participants in community-based drug-use research. Using an anonymous Web-based survey we psychometrically evaluated and examined relationships among six new scales tapping moral stress (frustration in response to perceived barriers to conducting research in a morally appropriate manner); organizational ethics climate; staff support; moral practice dilemmas (perceived conflicts between scientific integrity and participant welfare); research commitment; and research mistrust.As predicted, front-line researchers who evidence a strong commitment to their role in the research process and who perceive their organizations as committed to research ethics and staff support experienced lower levels of moral stress. Front-line researchers who were distrustful of the research enterprise and frequently grappled with moral practice dilemmas reported higher levels of moral stress.Applying psychometrically reliable scales to empirically examine research ethics challenges can illuminate specific threats to scientific integrity and human subjects protections encountered by front-line staff and suggest organizational strategies for reducing moral stress and enhancing the responsible conduct of research.

Celia B Fisher

Gala True

Leslie Alexander

Adam L Fried

Moral Stress, Moral Practice, and Ethical Climate in Community-Based Drug-Use Research: Views From the Front Line

道德压力、道德实践与社区药物使用研究中的伦理氛围：一线观点

Birth cohort studies of the natural history of pediatric common disease risk raise many bioethical issues, including re-consenting participants over time as children mature and cohort retention. Understanding participants' study-specific knowledge, attitudes, beliefs, and behavior may offer insights into these issues from a psychological perspective.We conducted an analysis of factors associated with parent-child communication about minor children's participation in a population-based birth cohort; children's knowledge about their own participation; and parental willingness to be re-contacted for future study among Swedish parents (N = 3,605) of children originally enrolled at birth in a prospective study of type 1 diabetes risk.More open parent-child communication about disease risk screening research and greater knowledge among children about their own research participation facilitated greater parent willingness to participate in further study. Parents' decisions about further study participation were most strongly favorable among those who communicated openly with their child and with high study-specific knowledge.Epidemiologists, bioethicists, and others involved in the design and conduct of large-scale, prospective birth cohorts may consider embedding periodic assessments of participants' study-specific attitudes and behavior to address long-term retention and willingness to engage in future research.

Kenneth P. Tercyak

Ulrica Swartling

Darren Mays

Suzanne Bennett Johnson

Johnny Ludvigsson

Behavioral Science Research Informs Bioethical Issues in the Conduct of Large-Scale Studies of Children's Disease Risk

行为科学研究为儿童疾病风险大规模研究中的生物伦理问题提供信息

出版信息	出版商: Taylor and Francis Ltd.，出版周期: ，期刊类型: journal，开源期刊: 否
基本数据	创刊年份: 2010，原创研究文献占比: ，自引率:， Gold OA占比:

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